Profiling gene expression dynamics underpinning conventional testing approaches to better inform pre-clinical evaluation of an age appropriate spironolactone formulation

References

• Agency EM. 2010. Report on the survey of all paediatric uses of medicinal products in Europe.
   Google Scholar
• Amaral JS, Pinho MJ, Soares-da-Silva P. 2008. Genomic regulation of intestinal amino acid transporters by aldosterone. Mol Cell Biochem. 313(1–2):1–10.
   PubMed Web of Science ®Google Scholar
• Artursson P, Karlsson J. 1991. Correlation between oral drug absorption in humans and apparent drug permeability coefficients in human intestinal epithelial (Caco-2) cells. Biochem Biophys Res Commun. 175(3):880–885.
   PubMed Web of Science ®Google Scholar
• Artursson P, Palm K, Luthman K. 2001. Caco-2 monolayers in experimental and theoretical predictions of drug transport. Adv Drug Deliv Rev. 46(1–3):27–43.
   PubMed Web of Science ®Google Scholar
• Batchelor HK, Fotaki N, Klein S. 2014. Paediatric oral biopharmaceutics: key considerations and current challenges. Adv Drug Deliv Rev. 73:102–126.
   PubMed Web of Science ®Google Scholar
• Boráň T, Menezes-Ferreira M, Reischl I, Celis P, Ferry N, Gänsbacher B, Krafft H, Lipucci di Paola M, Sladowski D, Salmikangas P, et al. 2017. Clinical development and commercialization of advanced therapy medicinal products in the European Union: how are the product pipeline and regulatory framework evolving? Hum Gene Ther Clin Dev. 28(3):126–135.
   PubMed Web of Science ®Google Scholar
• Castellani S, Guerra L, Favia M, Di Gioia S, Casavola V, Conese M. 2012. NHERF1 and CFTR restore tight junction organisation and function in cystic fibrosis airway epithelial cells: role of ezrin and the RhoA/ROCK pathway. Lab Invest. 92(11):1527–1540.
   PubMed Web of Science ®Google Scholar
• Chin WW, Joos A. 2016. Moving toward a paradigm shift in the regulatory requirements for pediatric medicines. Eur J Pediatr. 175(12):1881–1891.
   PubMed Web of Science ®Google Scholar
• Committee JF. 2020. BNF 79 (British National Formulary) March 2020. Pharmaceutical Press.
   Google Scholar
• Committee PB. 2019. National Formulary for Children 2019–2020. Pharmaceutical Press.
   Google Scholar
• Daneman R, Rescigno M. 2009. The gut immune barrier and the blood–brain barrier: are they so different? Immunity. 31(5):722–735.
   PubMed Web of Science ®Google Scholar
• González-Mariscal L, Tapia R, Chamorro D. 2008. Crosstalk of tight junction components with signaling pathways. Biochim Biophys Acta. 1778(3):729–756.
   PubMed Web of Science ®Google Scholar
• Granvil CP, Yu A-M, Elizondo G, Akiyama TE, Cheung C, Feigenbaum L, Krausz KW, Gonzalez FJ. 2003. Expression of the human CYP3A4 gene in the small intestine of transgenic mice: in vitro metabolism and pharmacokinetics of midazolam. Drug Metab Dispos. 31(5):548–558.
   PubMed Web of Science ®Google Scholar
• Guideline IHT, editor. 2005. Validation of analytical procedures: text and methodology Q2 (R1). International Conference on Harmonization; Geneva, Switzerland.
   Google Scholar
• Ieiri I, Takane H, Hirota T, Otsubo K, Higuchi S. 2006. Genetic polymorphisms of drug transporters: pharmacokinetic and pharmacodynamic consequences in pharmacotherapy. Expert Opin Drug Metab Toxicol. 2(5):651–674.
   PubMed Web of Science ®Google Scholar
• Kanehisa M, Sato Y, Furumichi M, Morishima K, Tanabe M. 2019. New approach for understanding genome variations in KEGG. Nucleic Acids Res. 47(D1):D590–D595.
   PubMed Web of Science ®Google Scholar
• Karim A, Kook C, Zitzewitz DJ, Zagarella J, Doherty M, Campion J. 1976. Species differences in the metabolism and disposition of spironolactone. Drug Metab Dispos. 4(6):547–555.
   PubMed Web of Science ®Google Scholar
• Kleemola M, Toivonen M, Mykkänen J, Simell O, Huoponen K, Heiskanen KM. 2007. Heterodimerization of y(+)LAT-1 and 4F2hc visualized by acceptor photobleaching FRET microscopy. Biochim Biophys Acta. 1768(10):2345–2354.
   PubMed Web of Science ®Google Scholar
• Kreeftmeijer-Vegter AR, de Boer A, van der Vlugt-Meijer RH, de Vries PJ. 2014. The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children. Orphanet J Rare Dis. 9(1):120.
   PubMed Web of Science ®Google Scholar
• Li Z-h, Deng Y, Cai H-l, Guo Z-h, Hou Z-y, Wu G, Yan M, Zhang B-k. 2016. Pharmacokinetic properties and bioequivalence of spironolactone tablets in fasting and fed healthy Chinese male subjects. Int J Clin Pharmacol Ther. 54(6):455–461.
   PubMed Web of Science ®Google Scholar
• Maron BA, Leopold JA. 2008. Mineralocorticoid receptor antagonists and endothelial function. Curr Opin Investig Drugs. 9(9):963–969.
   PubMedGoogle Scholar
• Meyer M, Schneckener S, Ludewig B, Kuepfer L, Lippert J. 2012. Using expression data for quantification of active processes in physiologically based pharmacokinetic modeling. Drug Metab Dispos. 40(5):892–901.
   PubMed Web of Science ®Google Scholar
• Mohammed AR, ElShaer AM, Jones RJ, Khan S, Russell CA. 2013. Drug bioavailability and gene profiling: challenges and opportunities for pharmaceutics and personalised medicine. In: Vizirianakis IS, editor. Handbook of personalized medicine: advances in nanotechnology, drug delivery and therapy. New York: Jenny Stanford Publishing; p. 141–190.
   Google Scholar
• Overdiek HW, Merkus FW. 1987. The metabolism and biopharmaceutics of spironolactone in man. Rev Drug Metab Drug Interact. 5(4):273–302.
   PubMedGoogle Scholar
• Pópulo H, Lopes JM, Soares P. 2012. The mTOR signalling pathway in human cancer. Int J Mol Sci. 13(2):1886–1918.
   PubMed Web of Science ®Google Scholar
• Pramar Y, Gupta VD. 1991. Preformulation studies of spironolactone: effect of pH, two buffer species, ionic strength, and temperature on stability. J Pharm Sci. 80(6):551–553.
   PubMed Web of Science ®Google Scholar
• Rigalli JP, Ruiz ML, Perdomo VG, Villanueva SSM, Mottino AD, Catania VA. 2011. Pregnane X receptor mediates the induction of P-glycoprotein by spironolactone in HepG2 cells. Toxicology. 285(1–2):18–24.
   PubMed Web of Science ®Google Scholar
• Ruiz ML, Villanueva SSM, Luquita MG, Pellegrino JM, Rigalli JP, Arias A, Sánchez Pozzi EJ, Mottino AD, Catania VA. 2009. Induction of intestinal multidrug resistance-associated protein 2 (Mrp2) by spironolactone in rats. Eur J Pharmacol. 623(1–3):103–106.
   PubMed Web of Science ®Google Scholar
• Russell C, Begum S, Hussain Y, Hussain M, Huen D, Rahman AS, Perrie Y, Mohammed AR. 2015. Paediatric drug development of ramipril: reformulation, in vitro and in vivo evaluation. J Drug Target. 23(9):854–863.
   PubMed Web of Science ®Google Scholar
• Russell C, Rahman A, Mohammed AR. 2013. Application of genomics, proteomics and metabolomics in drug discovery, development and clinic. Ther Deliv. 4(3):395–413.
   PubMedGoogle Scholar
• Scalise M, Pochini L, Console L, Losso MA, Indiveri C. 2018. The human SLC1A5 (ASCT2) amino acid transporter: from function to structure and role in cell biology. Front Cell Dev Biol. 6:96.
   PubMed Web of Science ®Google Scholar
• Takano M, Yumoto R, Murakami T. 2006. Expression and function of efflux drug transporters in the intestine. Pharmacol Ther. 109(1–2):137–161.
   PubMed Web of Science ®Google Scholar
• Testa B, Pedretti A, Vistoli G. 2012. Reactions and enzymes in the metabolism of drugs and other xenobiotics. Drug Discov Today. 17(11–12):549–560.
   PubMed Web of Science ®Google Scholar
• van Breemen RB, Li Y. 2005. Caco-2 cell permeability assays to measure drug absorption. Expert Opin Drug Metab Toxicol. 1(2):175–185.
   PubMedGoogle Scholar
• van der Vorst MMJ, Kist JE, van der Heijden AJ, Burggraaf J. 2006. Diuretics in pediatrics: current knowledge and future prospects. Paediatr Drugs. 8(4):245–264.
   PubMedGoogle Scholar
• Walsh J. 2017. Reflection on the pharmaceutical formulation challenges associated with a paediatric investigation plan for an off-patent drug. AAPS PharmSciTech. 18(2):250–256.
   PubMed Web of Science ®Google Scholar
• Yang Y, Faustino PJ, Volpe DA, Ellison CD, Lyon RC, Yu LX. 2007. Biopharmaceutics classification of selected beta-blockers: solubility and permeability class membership. Mol Pharm. 4(4):608–614.
   PubMed Web of Science ®Google Scholar